Data / Medical devices / United States / Isoaid, L.L.C.
Isoaid, L.L.C.: FDA-registered device maker in Port Richey, FL, United States, 6 510(k) clearances
Isoaid, L.L.C. is registered with the FDA (registration 3003440305) in Port Richey, FL, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 15, 2025. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003440305
- Address
- 7824 Clark Moody BLVD., Port Richey, FL, United States, 34668
- Owner or operator
- ISOAID, L.L.C. (9048520)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- November 23, 2001
- Registered through
- 2027
- Brand names listed
- Advantage, IsoSphere
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Needle; Orthopedic | HXK | 1 | Manufacturer | accessdata.fda.gov |
| Source, Brachytherapy, Radionuclide | KXK | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 15, 2025 | K242818 | IsoSphere | KXK | Substantially Equivalent | Isoaid, LLC | accessdata.fda.gov |
| December 5, 2014 | K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | KXK | Substantially Equivalent | Isoaid, LLC | accessdata.fda.gov |
| August 10, 2012 | K113210 | ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT | KXK | Substantially Equivalent | Isoaid, LLC | accessdata.fda.gov |
| September 15, 2009 | K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA | KXK | Substantially Equivalent | Isoaid, LLC | accessdata.fda.gov |
| April 8, 2004 | K033770 | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A | KXK | Substantially Equivalent | Isoaid, LLC | accessdata.fda.gov |
| July 10, 2001 | K011205 | ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 | KXK | Substantially Equivalent | Isoaid | accessdata.fda.gov |
Compare with other makers
- All makers of Source, Brachytherapy, Radionuclide
- All makers of Holder, Needle; Orthopedic
- All makers of System, Applicator, Radionuclide, Manual
Updated July 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.